Both Upadacitinib and Abrocitinib Demonstrate Real-World Efficacy in AD Patients After 1 Year

Image Credit: © dermnetnz.org

Positive retrospective study data has confirmed upadacitinib and abrocitinib's efficacy for moderate-to-severe atopic dermatitis (AD) in real-world settings.¹ Safety and effectiveness have been proven in phase 3 clinical trials, but long-term, real-world results have been limited for these JAK inhibitors.

For this trial, the AD database records of IRCCS Humanitas Research Hospital-Rozzano in Milan, Italy, were utilized. These electronic records were analyzed between January 2023 and December 2024. Information such as demographics, comorbidities, disease profile, and previous treatments was extracted.

Patients received either 15 or 30 mg of upadacitinib (n = 104) or 100 or 200 mg of abrocitinib (n = 25). Dosage was determined based on disease severity and age. A wash-out period of at least 4 weeks was advised before the trial began in those who had previously used systemic therapies for AD.

In the upadacitinib group, 50% of participants were male and 86.5% experienced AD in at least one sensitive area. In the abrocitinib group, 56% of participants were male and 72% experienced AD in at least one sensitive area. Mean ages were 36.65 and 39.56, respectively.

Investigator Global Assessment (IGA) and Eczema Area and Severity Index (EASI), along with patient-reported peak pruritus numerical rating scale (PP-NRS) and sleep-NRS scores, were used to evaluate at baseline and then weeks 8, 16, 32, and 52. Endpoints were similar to what was used in previous phase 3 trials for both drugs.

At baseline, patients treated with upadacitinib had a BMI of 23.84, a PP-NRS of 7.58, and a mean baseline EASI score of 19.22. Similarly, patients treated with abrocitinib had a mean BMI of 23.44, a PP-NRS of 7.24, and a mean baseline EASI score of 19.15. Disease duration was slightly longer in the upadacitinib group (23.45 years vs. 17.80, respectively).

Positive results were seen in both cohorts as early as 8 weeks into the trial. These rates continued to rise through 16 and 32 weeks. However, patients treated with abrocitinib at the same time point were less likely to achieve complete skin clearance (EASI 100) compared to those treated with upadacitinib (p = 0.017)

After 1 year of treatment with upadacitinib, 88.9% reached EASI75, 70.8% reached EASI90, and 54.2% reached complete skin clearance of EASI100. After 1 year of treatment with abrocitinib, 100% reached EASI75, 91.7% reached EASI90, and 75% reached EASI100.

After 52 weeks, 100% of patients taking abrocitinib reached IGA 0/1 compared to 84.7% of patients taking upadacitinib. However, for the entire study, there were no statistically significant differences between the 2 cohorts regarding absolute EASI score ≤ 7 and IGA score 0/1. Compared to baseline, a 4-point reduction from PP-NRS was observed in 86.1% of upadacitinib patients and 83.3% of abrocitinib patients after 1 year.

Previously reported and frequent adverse effects of abrocitinib include nausea, elevated serum creatine phosphokinase (CPK), and a decrease in platelet count.² In this study, acne and hypercholesterolemia were observed. Previously reported and frequent adverse effects of upadacitinib include acne, upper respiratory tract infections, nasopharyngitis, headache, and elevation of CPK.³ In this study, weight gain, microcomedonal acne, hypercholesterolemia, and herpes zoster infections were observed. No new safety findings were discovered in either group.

Several limitations, such as the retrospective study design and limited number of patients treated with abrocitinib, should be addressed in future research. Even so, these efficacy rates are similar or even higher than what was observed in phase 3 trials of each drug, including Measure Up-1, Measure Up-2, and JADE MONO-1. This study represents one of the largest and longest reported real-world AD populations to date.

References

1. Ibba L, Falcidia C, Di Giulio S, et al. Real-World Effectiveness and Safety of Upadacitinib and Abrocitinib in Moderate-to-Severe Atopic Dermatitis: A 52-Week Retrospective Study. J Clin Med. 2025;14(9):2953. Published 2025 Apr 24. doi:10.3390/jcm14092953

2. Simpson EL, Sinclair R, Forman S, et al. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2020;396(10246):255-266. doi:10.1016/S0140-6736(20)30732-7

3. Guttman-Yassky, E., Teixeira, H. D., Simpson, E. L., Papp, K. A., Pangan, A. L., Blauvelt, A., ... & Irvine, A. D. (2021). Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. The Lancet, 397(10290), 2151-2168.